Philips

  • Modelo / Serial
    Al lot codes
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
  • Descripción del producto
    Philips HEARTSTART Multifunction Electrode Pads || Part Number: M3718A
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Covidien LLC, 15 Hampshire St, Mansfield MA 02048-1113
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

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Más información acerca de la data acá

  • Modelo / Serial
    GEMINI TF 16 PET/CT and GEMINI TF 64 PET/CT
  • Descripción del producto
    Positron emission tomography technology and x-ray computed tomography.
  • Manufacturer
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